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BRAIN Initiative Cell Atlas Network (BICAN): Comprehensive Center on Human and Non-human Primate Brain Cell Atlases (UM1 Clinical Trial Not Allowed)

RFA
Tuesday, July 27, 2021
Wednesday, November 10, 2021
RFA-MH-21-235

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) intends to support a group of large-scale Comprehensive Centers that will adopt scalable technology platforms and streamlined sampling strategies and assay cascade to create comprehensive and highly granular brain cell atlases of human and non-human primates with an emphasis on human. The Centers are expected to characterize all brain cell types (neurons, glia, and other non-neuronal cells) at high-resolution. The overarching goal of the BICAN is to build reference brain cell atlases that will be widely used throughout the research community, providing a molecular and anatomical foundational framework for the study of brain function and disorders.

BRAIN Initiative Cell Atlas Network (BICAN): Coordinating Unit for Biostatistics, Informatics, and Engagement (CUBIE) (U24 Clinical Trial Not Allowed)

RFA
Tuesday, July 27, 2021
Wednesday, November 10, 2021
U24
RFA-MH-21-237

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) intends to support a Coordinating Unit for Biostatistics, Informatics, and Engagement (CUBIE) that will be composed of four components to establish respectively (1) a common sequencing data processing pipeline, (2) a common imaging data processing pipeline, (3) a comprehensive brain cell knowledge base, and (4) an engaging and outreach component to coordinate the research within and beyond BICAN. The overall goals of CUBIE are to (i) enable the exploration of large-scale brain cell atlas data and knowledge, and inspire research in brain function and disorders; and (ii) ensure research rigor and data reproducibility by making the data to be findable, accessible, interoperable, and reusable, and the process transparent. An application is expected to propose only one of the above four respective components.

BRAIN Initiative Cell Atlas Network (BICAN): Specialized Collaboratory on Human, Non-human Primate, and Mouse Brain Cell Atlases (U01 Clinical Trial Not Allowed)

RFA
Tuesday, July 27, 2021
Wednesday, November 10, 2021
U01
RFA-MH-21-236

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) intends to support a group of Specialized Collaboratories that will adopt scalable technology platforms and streamlined sampling strategies and assay cascade to create comprehensive and highly granular brain cell atlases in human, non-human primates, and mouse, in coordination and collaboration with other BICAN projects. In particular, the Specialized Collaboratories are expected to complement the Comprehensive Centers in BICAN with distinct capabilities, competencies, and research aims. The overarching goal of the BICAN is to build reference brain cell atlases that will be widely used throughout the research community, providing a molecular and anatomical foundational framework for the study of brain function and disorders.

Notice of Special Interest (NOSI): Research Supplements to Promote Re-Entry and Re-integration into Health-Related Research Careers (Admin Supp - Clinical Trial Not Allowed)

Notice of Special Interest
Friday, July 23, 2021
Saturday, October 7, 2023
333
NOT-OD-21-134

Funding Opportunity Purpose

The goal of this program is to provide support for a mentored research training experience for individuals with high potential to re-enter or re-integrate into an active research career, after an interruption for family responsibilities or other qualifying circumstances described below. This program encourages re-entry and re-integration administrative supplement applications to existing NIH research grants to support full or part-time mentored research experiences by these individuals. The supplement grants are intended to provide these scientists an opportunity to update or extend their research skills and knowledge and prepare them to re-establish their careers in basic biomedical, behavioral, clinical, translational, or social science research. It is anticipated that by the completion of the supplement support period, the re-entry/re-integration scientist will be prepared to apply for a fellowship (F), career development (K) award, a research award (R), or other types of independent research support.

NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)

PAR
Friday, July 16, 2021
Heal
Saturday, April 6, 2024
R41/R42
PAR-21-267
Emily Caporello

Funding Opportunity Purpose

(Reissue of PAR-18-617) The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Technology Transfer (STTR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only STTR Phase II and Fast-Track applications are supported under this program. STTR Phase I applications are only accepted as part of a Fast-track application.

NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)

PAR
Thursday, July 15, 2021
Saturday, April 6, 2024
R43/R44
PAR-21-266

Funding Opportunity Purpose

(Reissue of PAR-18-618) The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only SBIR Phase II and Fast-Track applications are supported under this program. SBIR Phase I applications are only accepted as part of a Fast-track application.

NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional)

PAR
Thursday, July 15, 2021
Translational Research, Clinical Trials Research, Clinical Research
Saturday, April 6, 2024
R44
PAR-21-265
Emily Caporello

Funding Opportunity Purpose

(Reissue of PAR-18-665) This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support clinical trials for projects that were previously funded by NIH SBIR and STTR Phase II awards. The projects must focus on products related to the mission and goals of the National Institute of Neurological Disorders and Stroke (NINDS) and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Since conducting the clinical trials needed for commercialization may be capital-intensive, the FOA aims to facilitate the transition of SBIR Phase II projects to the commercialization stage by promoting partnerships between NIH's SBIR/STTR awardees and third-party investors and/or strategic partners. Consistent with the goals of this funding initiative and as required by the SF424 instructions for all SBIR Phase II applications, applicants must submit a Commercialization Plan, which should include details on any independent third-party investor funding that has already been secured or is anticipated during the project period. It is expected that the level of this independent third-party funding will equal or exceed the NINDS funds being requested throughout the SBIR Phase IIB project period.

BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R01 Clinical Trial Optional)

RFA
Wednesday, July 14, 2021
Thursday, October 12, 2023
R01
RFA-MH-21-205

Funding Opportunity Purpose

Reissue of RFA-MH-19-400. This funding opportunity announcement (FOA), in support of the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, is one of several FOAs aimed at supporting transformative discoveries that will lead to breakthroughs in understanding human brain function. Guided by the long-term scientific plan, BRAIN 2025: A Scientific Vision, this FOA specifically seeks to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements supported by the BRAIN Initiative. The hope is that efforts supported under this FOA might be both complementary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative.

Notice of Special Interest: Advancing Research in Gastrointestinal Dysfunction in People with Neurodevelopmental Disorders

Notice of Special Interest
Wednesday, July 14, 2021
Wednesday, July 17, 2024
NOT-NS-22-003

Funding Opportunity Purpose

Gastrointestinal (GI) complications in children and adults with neurodevelopmental disorders have drawn attention to gaps in understanding their causes and treatment. GI dysfunction is particularly common in individuals with neurodevelopmental disorders such as autism, Fragile X syndrome, and Rett syndrome, as well as chromosomal disorders such as Down syndrome. GI disorders in these conditions can include gut malformations present at birth (such as pyloric stenosis or Hirschsprung disease) but also functional issues such as feeding problems, gastro-esophageal reflux disease (GERD), cyclic vomiting, delayed gastric emptying, diarrhea, bloating, celiac disease, irritable bowel symptoms, and constipation leading to encopresis, incontinence, and stool impaction. These GI issues may be associated with severe nutritional deficiencies, weight loss, and failure to thrive. GI symptoms are reported in between 23-70% of individuals with autism, a rate ~ 8 times higher than in the general population, with similar rates in individuals with other less common forms of intellectual and developmental disabilities (IDD) (Holingue et al., Autism Res 2018:11:24-36). Unfortunately, mechanisms to accurately diagnose GI conditions in this population are limited, and tailored treatments to address them are almost nonexistent, particularly since clinical trials for IDD populations are rare.

Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)

RFA
Tuesday, July 13, 2021
Saturday, October 9, 2021
UG3/UH3
RFA-HL-22-014

Funding Opportunity Purpose

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications are expected to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans. Successful applicants proposing the use of adult stem cells as a clinical intervention will be asked to make available representative samples of the source stem cell and clinical-grade stem cell-derived product for in-depth and independ

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